D-0364-2024 Class III Ongoing
FDA drug recall D-0364-2024 was initiated by Contract Pharmaceuticals Limited Canada on Feb 20, 2024 and is designated Class III. Reason for recall: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. The recall status is ongoing. Affected quantity: 45,875 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 13, 2024
- Initiation Date
- Feb 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,875 bottles
Product description
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Reason for recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Distribution pattern
Nationwide in the U.S. and Puerto Rico
Code information
Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0364-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026